Otrexup Generic: When Will Generic Methotrexate Be Available?

Otrexup’s Road to a Generic

Otrexup has had the market to itself since the FDA approved it in October 2013 (Cosette Pharmaceuticals Inc). Its 15 listed patents run to May 2031 (5 already expired).

The first generic of Otrexup is expected in May 2031.

Why that month: patent 8,814,834, on the product’s formulation, ends then.

Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.

Otrexup Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Otrexup’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.

The one that matters for a generic launch: patent 8,814,834, which ends in May 2031, the month the first generic is expected.

Source: FDA Orange Book, application 204824. Patent numbers open the patent on Google Patents.

Who Is Lined Up to Make Generic Methotrexate

Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.

Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).

Otrexup Price: What Pharmacies Pay and What Generics Usually Do

What Medicare and Medicaid Spend on Otrexup

Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.

Otrexup Strengths and Forms

Source: FDA Orange Book, Cosette Pharmaceuticals Inc. Listed for sale today by Antares Pharma, Inc. (FDA NDC Directory).

Otrexup NDC Codes and Packages

Each Otrexup package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.

Source: the FDA NDC Directory, current listings only. Only packages sold under Otrexup’s own FDA approval (NDA 204824) are listed, never a generic. Some codes belong to companies that repackage Otrexup: it is the same medicine in a different package.

Changes to This Projection

• October 2026First generic expected May 2031 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.

Every change to the expected month is logged here with the month we saw it.